Food, drugs, devices › Philips Medical Systems (Cleveland) Inc

Device recall: IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

FDA enforcement event 79148 · Class II · initiated 11 Jan 2018 · status Terminated · terminated 20 May 2019

DeviceVoluntary: Firm initiated1 product recordCleveland, OH

Philips Medical Systems (Cleveland) Inc (Cleveland, OH) initiated this device recall on 11 Jan 2018; FDA lists 1 product record under event 79148, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 20 May 2019. Initiation: voluntary: firm initiated. Philips Medical Systems (Cleveland) Inc has 129 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Philips Medical Systems (Cleveland) Inc, Cleveland, OH.

Reason for recall

"23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images."

Distribution

"Domestic and Foreign"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0841-2018	IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System	63	Class II	Terminated	14 Mar 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

129events on this register for the firm

Other enforcement events for Philips Medical Systems (Cleveland) Inc

Initiated	Product (first record)	Type	Class	Records
5 Aug 2025	Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)0088483	Device	Class II	1
17 Jul 2025	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software	Device	Class II	1
30 Aug 2022	Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.	Device	Class II	1
19 Sep 2019	Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit	Device	Class I	5
24 Jun 2019	Ingenuity CT, Model # 728326, computed tomography x-ray system	Device	Class II	9
10 Jun 2019	BrightView SPECT, Model Number 882480	Device	Class II	3
3 Jun 2019	Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sys	Device	Class II	1
19 Dec 2018	Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Em	Device	Class II	1
18 Oct 2018	Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images	Device	Class II	6
4 Sep 2018	Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnos	Device	Class II	1

All 129 events for Philips Medical Systems (Cleveland) Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Domestic and Foreign"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 20 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.